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Featured

Toon Lambrechts / Unsplash

Lessons From GAMP 5
Walter Nowocin
Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively. One notable exception is ISPE’s GAMP 5: “A risk-based approach to compliant GxP computerized systems.” More…

Supply Chain

New NIST Reference Strengthens Quality Control for Biological Drugs

A rapidly growing category of drugs called protein-based biotherapeutics can be used to treat cancers and genetic and autoimmune disorders. These drugs, which usually take the form of large protein molecules, are manufactured by growing living cells that are genetically engineered to produce the…

5 Essential Elements Shared by Leading Supplier Quality Management Systems

Global-scale events have tested the bounds of supply chain systems. The coronavirus, for example, made it clear how critical an efficient supply chain is for continuity and survival. It’s a real-world example of how important it is to have an enterprisewide system that uses a quality management…

Pharmaceutical Serialization

Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina. Recent estimations found that by 2022 serialization practices…

Accelerating Hardware Development to Improve National Security and Innovation

Modern fighter jets contain hundreds or even thousands of sensors. Some of those sensors collect data every second, others every nanosecond. For the engineering teams building and testing those jets, all those data points are hugely valuable—if they can make sense of them.

Nominal…

Supplier Scorecards vs. Spreadsheets

Spreadsheets are usually the first tool used to manage suppliers, and the first to become a liability. Important updates get buried. Repeat supplier problems start popping up. Along the way, you start to wonder whether that cheaper vendor is really saving you money in the long run.

…
Accountable When AI Fails?

On April 8, 2025, a driverless Zoox robotaxi misjudged an approaching vehicle, braked too late, and sideswiped it at 43 mph on the Las Vegas Strip.

One month later, the Amazon subsidiary issued a software recall on 270 autonomous vehicles and suspended operations while regulators…

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TÜV Rheinland North America Expands Accreditation
Boosts global compliance capabilities
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Permag Invests to Expand Domestic Samarium Cobalt Magnet Manufacturing
The only US-based producer of these magnets will establish a secure, domestic supply chain of critical magnetics
TASI Measurement Acquires Dciii
Expanding capabilities in chemical injection automation
3D Printing Reshapes Construction for Nuclear Energy
A compelling vision for lowering the cost and timeline of future reactors
BLT Delivers Critical Components for Space Circling
3D printing propels QL-1 rocket engine
4 Innovative Ways ORNL Quantum Tech Supports Industry
From healthcare to entrepreneurship
LMA Announces Advocate and Futurist Award Winners
Part of the firm’s 20th anniversary celebration
more news

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